Work Schedule Standard (Mon-Fri)Environmental Conditions Adherence to all Good Manufacturing Practices (GMP) Safety StandardsJob DescriptionTechnical ResponsibilitiesProcesses and methods implementation:
Coordinate actions to establish and implement processes and analytical methods for testing finished products, in-process controls, intermediates, raw materials, utility, and cleaning samples.
Responsible for:
Write and revise standard operating procedures (SOPs) and work instructions (Wis) within timelines
Review and approve methods, plans, protocols, and reports
Supporting procurement, qualification, calibration, and maintenance of analytical and infrastructure equipment
Coordinate the development, transfer, and validation of analytical procedures according to given timelines
Review of analytical raw data, equipment qualification/maintenance raw data, and other documentation in Biochemical QC.
Project Leadership:
Represent BCQC in projects, workgroups, and participate in local and global initiatives
Promote effective and timely communication within project teams, ensuring visibility and understanding of the site/company's strategy
Support project implementation within the QC department and ensure data-driven workload for each assigned project
Drive project collaboration and operate in full alignment with the company's core values
Own the problem-solving process for any issues related to assigned projects/tasks
Coordinate resources in collaboration with the rest of QC, ensuring QC timelines and targets are met
Promote an accountable working environment through management mentorship and open access to important information
Proactively support continuous improvement of QC compliance and performance
Establish and maintain contact with external partners such as suppliers, contract laboratories, and universities
QC Execution:
Document and deposit raw data, results, reports, and journals
Assist during the resolution of issues and requests related to (bio)chemical analytics (quality issues, health authority requests, etc.)
Ensure timely investigation of deviations
Communicate efficiently and inform the head of BCQC about ongoing business and issues
Sharing required information with sponsors, customers, and colleagues
Supporting QC colleagues in the areas of GMP and Quality Control
Supporting recruitment within the team
Acting as liaisons between their respective departmental teams and the DI officer, ensuring regular DI Surveillance and performing internal DI moments, huddles, and trainings
Position QualificationEducation:
Degree or equivalent experience (Master or higher) in biochemical, chemical, pharmaceutical, molecular sciences, or similar fields.
Lower educational background may be accepted based on significant experience in the pharmaceutical industry.
Experience & Proficiencies:
3-5 years lab experience with confirmed expertise in (bio)chemical QC methods, method validation, and analytical issue management
confirmed experience (at least 5 years) in chemical or biochemical laboratories, including experience in a regulated GMP environment
experience in project and task coordination
Proficiencies:
Business insight and critical thinking
Emphasis on achieving goals and taking ownership
Effective communication skills
Strong collaboration abilities
Agility and adaptability in handling ambiguity
Additional Requirements:
Proficiency in English and German is required, with exceptions considered on a case-by-case basis based on the overall CV.
